Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ARTELAC
|
Active substances:
|
|
ATC code:
|
S01XA82
|
Dosage form:
|
eye drops, solution
|
Strength:
|
3,2mg 1ml
|
Legal status for supply*:
|
Not subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated October 18, 2023)
|
Package information leaflet (PIL):
|
EST (last updated October 18, 2023)
|
Translation of package information leaflet into Russian:
|
RUS (last updated January 13, 2021)
|
Translation of package information leaflet into English:
|
ENG (last updated January 13, 2021)
|
Labelling:
|
(last updated October 18, 2023)
|
Indication:
|
Symptomatic treatment of dessication of the cornea and conjunctiva which are caused by disturbed tear secretion due to local or systemic diseases and/or change in the composition of tear fluid, deficient eyelid or incomplete eyelid closure.
|
Marketing authorization holder:
|
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
|
Marketing authorization number:
|
269099
|
Marketing authorization issued on:
|
June 14, 1999
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
National
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1038136
|
ARTELAC
|
eye drops, solution
|
3,2mg 1ml 10ml 1TK
|
OTC
|
|
|
22.03.2024
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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